跳至主要内容
临床试验/NCT07507266
NCT07507266尚未招募不适用

Evaluation of Emotions From Salivary Molecular Biomarkers in an Architectural Context

Sys2Diag1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Evaluate the variation of salivary biomarkers, which may be linked to emotions (positive or negative), before and after interaction with an architectural work.

研究概览

简要总结

Architecture influences our well-being. People's behavior and mood changes in different spaces are directly related to the architectural qualities of the built environment. Neuroarchitecture is a discipline that combines neuroscience and architecture to design spaces adapted to the psychological and physiological needs of users. Several studies related to neuroarchitecture have been conducted according to different architectural parameters such as style, natural environment, lighting, color, and sunlight pattern. Recent studies show that emotional states can be evaluated by physiological responses. This physiological regulation comes from the action of enzymes and hormones that represent the activity of the autonomic nervous system. Measuring specific biomarkers through non-invasive biological tests in saliva provides physiological data on an individual's emotional state in response to stimuli, particularly visual or tactile.

详细描述

Architecture influences our well-being, and people's behavior and mood changes in different spaces are directly related to the architectural qualities of the built environment. For example, noise and lack of vegetation can generate stress and stress associated with the built environment can even negatively impact life expectancy. Moreover, psychology, and more specifically emotional regulation, plays a fundamental role in how individuals perceive and react to their environment. Emotional regulation is closely linked to the attachment style developed during childhood. Studies have shown that insecure attachment is associated with poorer emotional regulation, which can amplify stress reactions in response to an environment perceived as hostile or inadequate. Neuroarchitecture is a discipline that combines neuroscience and architecture to design spaces adapted to the psychological and physiological needs of users. Its main objective is to create environments that positively influence emotions and well-being, taking into account how our brain perceives and reacts to different elements of space. Several studies related to neuroarchitecture have been conducted according to different architectural parameters such as style, natural environment, lighting, color, and sunlight pattern. These studies generally use tools such as self-assessment scales (e.g., PANAS for affect), functional magnetic resonance imaging (fMRI), electroencephalogram (EEG), and heart rate measurement. These often subjective or indirect methods require trained and/or medical personnel and heavy equipment. In addition, emotions and their regulation are influenced by several sociodemographic factors, including age and the development of the prefrontal cortex, but also gender, socioeconomic level, education level, and cultural context. These factors modulate exposure to stress, the available regulation strategies, and their effectiveness. Life history, particularly early exposure to traumatic events, is also determining. These elements justify the attention paid to inclusion and exclusion criteria in the study (particularly age, gender, cultural context, etc.) to best control these variables. Recent studies show that emotional states (positive and negative) can also be evaluated by physiological responses. This physiological regulation comes from the action of enzymes and hormones that represent the activity of the autonomic nervous system. Thus, several studies using the Trier Social Stress Test (TSST) have highlighted an increase in the concentration of cortisol, DeHydroEpiAndrosterone (DHEA), and salivary alpha-amylase in response to a state of acute stress and anxiety in tested individuals. Glenk et al. studied 40 adults (21 to 34 years old, allergic or not) using measures such as the State-Trait Anxiety Inventory (STAI-S) (20 self-reported items), the Emotion Regulation Questionnaire (ERQ), a visual analog scale of perceived stress (VAS), salivary cortisol measurements, and plasma oxytocin. Izawa et al. analyzed salivary DHEA levels, blood pressure, and heart rate in 33 students with an average age of 22. Van Stegeren et al. measured salivary cortisol and alpha-amylase in 80 adults (men and women) exposed to TSST. Furthermore, an association between positive emotions and a decrease in salivary cortisol has also been described by Lai et al. in 80 adults via a questionnaire and salivary cortisol analysis. Oxytocin modulates the integration of emotional information and interacts with the reward pathway. It is released during positive social interactions and can downregulate stress and heart rate (study of 163 young adults under 35, high school level, no medication, questionnaires, filmed interviews, blood oxytocin measurement). Finally, Kanen et al. showed that fluctuations in serotonin concentration can generate various emotional phenotypes, highlighting the neurobiological impact on emotional regulation. It is therefore essential that participation in architectural exposure is voluntary, as the perception of control is a key factor in modulating the emotional response. Finally, measuring specific biomarkers (enzymes, hormones) through non-invasive biological tests in saliva provides reliable physiological data on an individual's emotional state). These approaches have already been applied to analyze the effects of olfactory stimuli (study of 170 participants, questionnaires, and salivary biomarkers) or architectural. The objective of the proposed research is therefore to measure, in an immersive context (architecture festival), salivary molecular biomarkers known to be linked to emotions. These measurements are intended to objectively measure the influence of an architectural context on physiological parameters related to emotions, while taking into account the psychological, sociodemographic, and developmental factors identified through a dedicated questionnaire.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject over 18 years old
  • Subject agreeing to follow the study procedures
  • Subject capable of understanding the purpose, nature, and methodology of the study
  • Subject affiliated with a French social security scheme or beneficiary of such a scheme.

排除标准

  • Subject not affiliated with a French Social Security scheme or not a beneficiary of such a scheme
  • Subject deprived of liberty, protected adult, vulnerable person, or minor
  • Subject with proven or suspected chronic infectious disease that could pose a risk of contamination during sample handling (laboratories not equipped to handle this type of sample)
  • Subject with a deficiency (vision, anosmia) preventing proper interaction with the architectural work
  • Subject presenting signs of active oral inflammation, advanced periodontitis, or severe gingivitis
  • Subject suffering from Gougerot-Sjögren syndrome (dry syndrome) or mouth cancer
  • Pregnant or breastfeeding women.

研究组 & 干预措施

ARM O

30 subjects who will be exposed to a second architectural work offering visual, tactile, and olfactory stimulations.

干预措施: Bio-fluid analysis for the measurement of salivary biomarkers linked to emotions (Diagnostic Test)

ARM VT

30 subjects who will be exposed to an architectural work offering visual and tactile stimulations.

干预措施: Bio-fluid analysis for the measurement of salivary biomarkers linked to emotions (Diagnostic Test)

结局指标

主要结局

Evaluate the variation of salivary biomarkers, which may be linked to emotions (positive or negative), before and after interaction with an architectural work.

时间窗: 2 years

Evaluate the variation of salivary biomarkers, which may be linked to emotions (positive or negative), before and after interaction with an architectural work. This exposure includes a combination of visual, tactile, and/or olfactory stimuli.

次要结局

  • Identify a salivary molecular biomarker signature linked to an emotional profile following exposure to an architectural site.(2 years)
  • Compare the identified molecular biomarker signatures between the studied architectural sites (different types of visual, tactile, or olfactory stimuli).(2 years)
  • Establish correlations between the identified biomarker signatures linked to emotional profiles and sociodemographic and developmental data.(2 years)
  • Evaluate the homogeneity of the emotional physiological response following exposure to an architectural site.(2 years)

研究者

发起方
Sys2Diag
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Laurence MOLINA

Senior Researcher/Project Manager

Sys2Diag

研究点 (1)

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